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General |
Study Status |
Completed |
Application Number / Requirement Number |
P810002 S101/ PAS001 |
Date Original Protocol Accepted |
03/06/2018
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Date Current Protocol Accepted |
 
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Study Name |
Cont f/u of the premarket HALO Cohort
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Device Name |
SJM Masters Series Mechanical Heart Valve, 15mm HP
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General Study Protocol Parameters |
Study Design |
Prospective & Retrospective Study
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Data Source |
Sponsor Registry
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Comparison Group |
No Control
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Analysis Type |
Descriptive
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Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs
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Detailed Study Protocol Parameters |
Study Objectives |
The objective of this study is to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm mitral mechanical heart valve as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning mitral valve.
The study includes continued follow-up of patients enrolled in the HALO study, which was a single arm, prospective, non-randomized, multi-center clinical trial of the SJM™ Masters Series Hemodynamic HP 15mm mitral heart valve.
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Study Population |
The study population consists of pediatric subjects that are 5 years or less in age with a diseased, damaged, or malfunctioning mitral heart valve.
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Sample Size |
This study will continue to follow subjects that are alive and in which the valve is still implanted from the following groups: Subjects enrolled in the HALO study, Subjects enrolled under Continued Access, and Emergency/compassionate use subjects who have consented for prospective follow-up.
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Key Study Endpoints |
The following adverse events (if determined to be valve related and serious) will be summarized annually with descriptive statistics: Death; Endocarditis; Hemorrhage (whether or not due to anticoagulant/antiplatelet medication); Nonstructural dysfunction (including perivalvular leak, hemolysis, and hemolytic anemia); Reoperation (including valve explant, not due to anatomical growth of the subject); Structural valve deterioration; Thromboembolism; and Valvular thrombosis. The following effectiveness endpoints will be reported at any/all time point(s) available: Mean gradient as assessed by echocardiography; Peak gradient as assessed by echocardiography; and Valvular regurgitation grade as assessed by echocardiography.
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Follow-up Visits and Length of Follow-up |
Study subjects will be followed annually either for five years from the date of implant, until subject withdrawal, or until end of device use, whichever occurs earliest.
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
23 (20 IDE & 3 CAP)
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Actual Number of Sites Enrolled |
15
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Patient Follow-up Rate |
The final study follow-up rate at 5 years is 95.6% (22/23)
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Final Safety Findings |
At 12 months, the K-M freedom from valve-related adverse events was 64.3% for all study subjects. Within 12 months of implant, the following CEC-Adjudicated Valve-related Adverse Events occurred: 6 all-cause deaths, 1 endocarditis, 5 all hemorrhage, 1 nonstructural dysfunction, 5 reoperations, 1 thromboembolism, and 5 thrombus on device. Between 12 months and 5-years, the following additional events occurred: 2 all hemorrhage, 1 nonstructural dysfunction, and 2 reoperations.
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Final Effect Findings |
Patients showed improvement from baseline in peak and mean valve gradient and valve regurgitation until valve was removed/replaced due to anatomical growth.
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Study Strengths & Weaknesses |
One strength of the study was that it had a high follow-up rate (95.6%) with only 1 patient lost to follow-up. A weakness of the study is that it is a single arm study with a smaller sample size.
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Recommendations for Labeling Changes |
Updates to the labeling are recommended
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